An observational study in Crohn's Disease, Rheumatoid Arthritis and Psoriasis, sponsored by AbbVie. Completed. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-06-19.
Sponsored by AbbVie · Observational
For public health purposes disability is becoming increasingly important as an outcome measure. Despite this, there are few data on the effectiveness of adalimumab on disability outcomes in patients with immune-mediated inflammatory diseases (IMIDs), particularly in the Phase IV setting. There are even less data available in New Zealand, which did not have the opportunity to participate to a major extent in large, multinational, Phase III pivotal studies of adalimumab in IMIDs.
The World Health Organisation Disability Assessment Schedule (WHODAS) 2.0 is a simple, validated, free and easy-to-use generic assessment instrument for health and disability. It is applicable across cultures, in all adult populations. It is a responsive measure that can show what difference a treatment makes.
Results from study of effect of adalimumab on WHODAS scores and other patient-reported outcomes (PROs) of work activity and well-being will be of interest to a variety of stakeholders in the healthcare system including patients, healthcare practitioners and payers.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 168 is close to the median of 155 across 1,057 observational studies indexed under Arthritis.
Browse Arthritis studies →AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.
Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
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Subjects will be males and/or females who are attending a routine clinical visit and meet all of the inclusion criteria and none of the exclusion criteria.
Exclusion Criteria:
Participants with Crohn's disease. All participants will receive at least 3 months of treatment with adalimumab. Adalimumab was prescribed by the physician under usual and customary practice and according to the approved adalimumab New Zealand Datasheet.
Participants with rheumatoid arthritis. All participants will receive at least 3 months of treatment with adalimumab. Adalimumab was prescribed by the physician under usual and customary practice and according to the approved adalimumab New Zealand Datasheet.
Participants with psoriasis. All participants will receive at least 3 months of treatment with adalimumab. Adalimumab was prescribed by the physician under usual and customary practice and according to the approved adalimumab New Zealand Datasheet.
Change From Baseline in WHODAS 2.0 Response Score at Month 6 Across All Indications
WHODAS 2.0 is a measures health and disability across cultures in all adult populations by assessing the same individual before and after the intervention across 12 items, covering the following 6 domains: cognition, mobility, self-care, getting along, life activities and participation. Scores assigned to each of the items (none=0, mild=1, moderate=2, severe=3, and extreme=4) are summed. Scores can range from 0 to 48. Persons scoring 10 to 48 are likely to have clinically significant disability.
Time frame: Baseline, Month 6
Change From Baseline in WHODAS 2.0 Response Score at Month 2 Across All Indications
WHODAS 2.0 is a measures health and disability across cultures in all adult populations by assessing the same individual before and after the intervention across 12 items, covering the following 6 domains: cognition, mobility, self-care, getting along, life activities and participation. Scores assigned to each of the items (none=0, mild=1, moderate=2, severe=3, and extreme=4) are summed. Scores can range from 0 to 48. Persons scoring 10 to 48 are likely to have clinically significant disability.
Time frame: Baseline, Month 2
Change From Baseline in WHODAS 2.0 Response Score at Month 4 Across All Indications
WHODAS 2.0 is a measures health and disability across cultures in all adult populations by assessing the same individual before and after the intervention across 12 items, covering the following 6 domains: cognition, mobility, self-care, getting along, life activities and participation. Scores assigned to each of the items (none=0, mild=1, moderate=2, severe=3, and extreme=4) are summed. Scores can range from 0 to 48. Persons scoring 10 to 48 are likely to have clinically significant disability.
Time frame: Baseline, Month 4
Change From Baseline in WHODAS 2.0 Response Score at Month 6 in Participants With Crohn's Disease
WHODAS 2.0 is a measures health and disability across cultures in all adult populations by assessing the same individual before and after the intervention across 12 items, covering the following 6 domains: cognition, mobility, self-care, getting along, life activities and participation. Scores assigned to each of the items (none=0, mild=1, moderate=2, severe=3, and extreme=4) are summed. Scores can range from 0 to 48. Persons scoring 10 to 48 are likely to have clinically significant disability.
Time frame: Baseline, Month 6
Change From Baseline in WHODAS 2.0 Response Score at Month 6 In Participants With Psoriasis
WHODAS 2.0 is a measures health and disability across cultures in all adult populations by assessing the same individual before and after the intervention across 12 items, covering the following 6 domains: cognition, mobility, self-care, getting along, life activities and participation. Scores assigned to each of the items (none=0, mild=1, moderate=2, severe=3, and extreme=4) are summed. Scores can range from 0 to 48. Persons scoring 10 to 48 are likely to have clinically significant disability.
Time frame: Baseline, Month 6
Change From Baseline in WHODAS 2.0 Response Score at Month 6 in Participants With Rheumatoid Arthritis
WHODAS 2.0 is a measures health and disability across cultures in all adult populations by assessing the same individual before and after the intervention across 12 items, covering the following 6 domains: cognition, mobility, self-care, getting along, life activities and participation. Scores assigned to each of the items (none=0, mild=1, moderate=2, severe=3, and extreme=4) are summed. Scores can range from 0 to 48. Persons scoring 10 to 48 are likely to have clinically significant disability.
Time frame: Baseline, Month 6
Change From Baseline in WPAI:GH V2.0 Score at Month 6 Across All Indications: Absenteeism
WPAI:GH is a 6-item questionnaire looks at the effect of health problems on ability to work and perform regular activities. The WPAI yields 4 types of scores: absenteeism (work time missed), presenteeism (impairment at work / reduced on-the-job effectiveness), work productivity loss (overall work impairment / absenteeism plus presenteeism) and activity impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. The questionnaire specifies responses for the previous 7 days.
Time frame: Baseline, Month 6
Change From Baseline in WPAI:GH V2.0 Score at Month 6 Across All Indications: Presenteeism
WPAI:GH is a 6-item questionnaire looks at the effect of health problems on ability to work and perform regular activities. The WPAI yields 4 types of scores: absenteeism (work time missed), presenteeism (impairment at work / reduced on-the-job effectiveness), work productivity loss (overall work impairment / absenteeism plus presenteeism) and activity impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. The questionnaire specifies responses for the previous 7 days.
Time frame: Baseline, Month 6
Change From Baseline in WPAI:GH 2.0 Score at Month 6 Across All Indications: Work Productivity Loss
WPAI:GH is a 6-item questionnaire looks at the effect of health problems on ability to work and perform regular activities. The WPAI yields 4 types of scores: absenteeism (work time missed), presenteeism (impairment at work / reduced on-the-job effectiveness), work productivity loss (overall work impairment / absenteeism plus presenteeism) and activity impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. The questionnaire specifies responses for the previous 7 days.
Time frame: Baseline, Month 6
Change From Baseline in WPAI:GH V2.0 Score at Month 6 Across All Indications: Activity Impairment
WPAI:GH is a 6-item questionnaire looks at the effect of health problems on ability to work and perform regular activities. The WPAI yields 4 types of scores: absenteeism (work time missed), presenteeism (impairment at work / reduced on-the-job effectiveness), work productivity loss (overall work impairment / absenteeism plus presenteeism) and activity impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. The questionnaire specifies responses for the previous 7 days.
Time frame: Baseline, Month 6
Change From Baseline in K10 at Month 6 Across All Indications
The K10 is intended to yield a global measure of distress based on a questionnaire about anxiety and depressive symptoms that a person has experienced in the most recent 4 week period. The K10 scale involves 10 questions about emotional states each with a 5-level response scale. Each item is scored from 1=none of the time to 5=all of the time. Scores of the 10 items are then summed, yielding a minimum score of 10 and a maximum score of 50. Low scores indicate low levels of psychological distress and high scores indicate high levels of psychological distress.
Time frame: Baseline, Month 6
Change From Baseline in Flourishing Scale at Month 6 Across All Indications
The Flourishing Scale is a brief 8-item summary measure of the respondent's self-perceived success in important areas such as relationships, self-esteem, purpose, and optimism. The scale provides a single psychological well-being score. Participants are asked to respond to 8 statements using a scale of 1 (strongly disagree) and 7 (strongly agree) for each item. The possible range of scores is from 8 (lowest possible) to 56 (highest possible), with higher scores representing more psychological resources and strengths.
Time frame: Baseline, Month 6
Change From Baseline in Subjective Vitality Scale at Month 6 Across All Indications
The Subjective Vitality Scale assesses the state of feeling alive and alert to having energy available to the self. Patients respond to eight prompts, with a response ranging from 1=strongly disagree to 7=strongly agree. The sum of the scores is calculated with a higher score indicating a better condition. The total score ranges from 8 to 56 with a higher score indicating a better condition.
Time frame: Baseline, Month 6
Change From Baseline in HAQ-DI Score at Month 6 in Participants With Rheumatoid Arthritis
HAQ-DI measures functional status in rheumatic diseases. It has 20 items, and asks patients to report the degree of difficulty faced in several areas of their life including: dressing and grooming, arising, eating, walking, hygiene, reach, grip, activities based on the previous week on a scale from 0 (without any difficulty) to 3 (cannot be done at all). It also asks the participant to rate their pain and health in the previous week. Scores on each task are summed and averaged to provide an overall score ranging from 0 (no disability) to 3 (very severe, high-dependency disability).
Time frame: Baseline, Month 6
Change From Baseline in SIBDQ Score at Month 6 in Participants With Crohn's Disease
The SIBDQ is a simple validated, 10-item questionnaire designed to find out how the patient has been feeling in the previous 2 weeks. QoL is measured in 4 domains: bowel symptoms, emotional health, systemic systems and social function. Participants respond to questions ranging from 1=all of the time to 7=none of the time. Scores are added together, with higher scores indicating a better health-related QoL. Total scores range from 10 (poor QoL) to 70 (good QoL).
Time frame: Baseline, Month 6
Change From Baseline in DLQI Score at Month 6 in Participants With Psoriasis
The DLQI measures 10 items covering the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment, to determine how much the patients skin problem affected their life in the past week. Participants respond to the questions with 'very much,' 'a lot,' 'a little,' or 'not at all.' The scores are added together, and the impact on QoL is banded as follows: 0-1=no effect on participant's life; 2-5=small effect; 6-10=moderate effect; 11-20=very large effect; 21-30=extremely large effect.
Time frame: Baseline, Month 6
Number of Participants Remaining on Treatment at Month 6
The number of participants at 6 months who remained on adalimumab, having satisfied the requirements for application for renewal of subsidy by special authority.
Time frame: Month 6
| Milestone | Crohn's Disease | Rheumatoid Arthritis | Psoriasis |
|---|---|---|---|
| Started | 72 | 59 | 37 |
| Baseline whodas data recorded | 70 | 57 | 37 |
| Completed | 44 | 40 | 30 |
| Not completed | 28 | 19 | 7 |
WHODAS 2.0 is a measures health and disability across cultures in all adult populations by assessing the same individual before and after the intervention across 12 items, covering the following 6 domains: cognition, mobility, self-care, getting along, life activities and participation. Scores assigned to each of the items (none=0, mild=1, moderate=2, severe=3, and extreme=4) are summed. Scores can range from 0 to 48. Persons scoring 10 to 48 are likely to have clinically significant disability.
| units on a scale | All Indications |
|---|---|
| Change From Baseline in WHODAS 2.0 Response Score at Month 6 Across All Indications | 7.9 ± 8.1 |
WHODAS 2.0 is a measures health and disability across cultures in all adult populations by assessing the same individual before and after the intervention across 12 items, covering the following 6 domains: cognition, mobility, self-care, getting along, life activities and participation. Scores assigned to each of the items (none=0, mild=1, moderate=2, severe=3, and extreme=4) are summed. Scores can range from 0 to 48. Persons scoring 10 to 48 are likely to have clinically significant disability.
| units on a scale | All Indications |
|---|---|
| Change From Baseline in WHODAS 2.0 Response Score at Month 2 Across All Indications | 5.7 ± 8.0 |
WHODAS 2.0 is a measures health and disability across cultures in all adult populations by assessing the same individual before and after the intervention across 12 items, covering the following 6 domains: cognition, mobility, self-care, getting along, life activities and participation. Scores assigned to each of the items (none=0, mild=1, moderate=2, severe=3, and extreme=4) are summed. Scores can range from 0 to 48. Persons scoring 10 to 48 are likely to have clinically significant disability.
| units on a scale | All Indications |
|---|---|
| Change From Baseline in WHODAS 2.0 Response Score at Month 4 Across All Indications | 7.1 ± 8.4 |
WHODAS 2.0 is a measures health and disability across cultures in all adult populations by assessing the same individual before and after the intervention across 12 items, covering the following 6 domains: cognition, mobility, self-care, getting along, life activities and participation. Scores assigned to each of the items (none=0, mild=1, moderate=2, severe=3, and extreme=4) are summed. Scores can range from 0 to 48. Persons scoring 10 to 48 are likely to have clinically significant disability.
| units on a scale | Crohn's Disease |
|---|---|
| Change From Baseline in WHODAS 2.0 Response Score at Month 6 in Participants With Crohn's Disease | 6.3 ± 7.3 |
WHODAS 2.0 is a measures health and disability across cultures in all adult populations by assessing the same individual before and after the intervention across 12 items, covering the following 6 domains: cognition, mobility, self-care, getting along, life activities and participation. Scores assigned to each of the items (none=0, mild=1, moderate=2, severe=3, and extreme=4) are summed. Scores can range from 0 to 48. Persons scoring 10 to 48 are likely to have clinically significant disability.
| units on a scale | Psoriasis |
|---|---|
| Change From Baseline in WHODAS 2.0 Response Score at Month 6 In Participants With Psoriasis | 8.1 ± 8.9 |
WHODAS 2.0 is a measures health and disability across cultures in all adult populations by assessing the same individual before and after the intervention across 12 items, covering the following 6 domains: cognition, mobility, self-care, getting along, life activities and participation. Scores assigned to each of the items (none=0, mild=1, moderate=2, severe=3, and extreme=4) are summed. Scores can range from 0 to 48. Persons scoring 10 to 48 are likely to have clinically significant disability.
| units on a scale | Rheumatoid Arthritis |
|---|---|
| Change From Baseline in WHODAS 2.0 Response Score at Month 6 in Participants With Rheumatoid Arthritis | 9.5 ± 8.3 |
WPAI:GH is a 6-item questionnaire looks at the effect of health problems on ability to work and perform regular activities. The WPAI yields 4 types of scores: absenteeism (work time missed), presenteeism (impairment at work / reduced on-the-job effectiveness), work productivity loss (overall work impairment / absenteeism plus presenteeism) and activity impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. The questionnaire specifies responses for the previous 7 days.
| percentage of work time missed | All Indications |
|---|---|
| Change From Baseline in WPAI:GH V2.0 Score at Month 6 Across All Indications: Absenteeism | 10.6 ± 34.7 |
WPAI:GH is a 6-item questionnaire looks at the effect of health problems on ability to work and perform regular activities. The WPAI yields 4 types of scores: absenteeism (work time missed), presenteeism (impairment at work / reduced on-the-job effectiveness), work productivity loss (overall work impairment / absenteeism plus presenteeism) and activity impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. The questionnaire specifies responses for the previous 7 days.
| percentage impairment time | All Indications |
|---|---|
| Change From Baseline in WPAI:GH V2.0 Score at Month 6 Across All Indications: Presenteeism | 18.0 ± 33.1 |
WPAI:GH is a 6-item questionnaire looks at the effect of health problems on ability to work and perform regular activities. The WPAI yields 4 types of scores: absenteeism (work time missed), presenteeism (impairment at work / reduced on-the-job effectiveness), work productivity loss (overall work impairment / absenteeism plus presenteeism) and activity impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. The questionnaire specifies responses for the previous 7 days.
| percentage overall work impairment | All Indications |
|---|---|
| Change From Baseline in WPAI:GH 2.0 Score at Month 6 Across All Indications: Work Productivity Loss | 9.7 ± 28.0 |
WPAI:GH is a 6-item questionnaire looks at the effect of health problems on ability to work and perform regular activities. The WPAI yields 4 types of scores: absenteeism (work time missed), presenteeism (impairment at work / reduced on-the-job effectiveness), work productivity loss (overall work impairment / absenteeism plus presenteeism) and activity impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. The questionnaire specifies responses for the previous 7 days.
| percentage of activity impariment | All Indications |
|---|---|
| Change From Baseline in WPAI:GH V2.0 Score at Month 6 Across All Indications: Activity Impairment | 24.1 ± 34.0 |
The K10 is intended to yield a global measure of distress based on a questionnaire about anxiety and depressive symptoms that a person has experienced in the most recent 4 week period. The K10 scale involves 10 questions about emotional states each with a 5-level response scale. Each item is scored from 1=none of the time to 5=all of the time. Scores of the 10 items are then summed, yielding a minimum score of 10 and a maximum score of 50. Low scores indicate low levels of psychological distress and high scores indicate high levels of psychological distress.
| units on a scale | All Indications |
|---|---|
| Change From Baseline in K10 at Month 6 Across All Indications | 6.1 ± 7.7 |
The Flourishing Scale is a brief 8-item summary measure of the respondent's self-perceived success in important areas such as relationships, self-esteem, purpose, and optimism. The scale provides a single psychological well-being score. Participants are asked to respond to 8 statements using a scale of 1 (strongly disagree) and 7 (strongly agree) for each item. The possible range of scores is from 8 (lowest possible) to 56 (highest possible), with higher scores representing more psychological resources and strengths.
| units on a scale | All Indications |
|---|---|
| Change From Baseline in Flourishing Scale at Month 6 Across All Indications | -2.3 ± 8.7 |
The Subjective Vitality Scale assesses the state of feeling alive and alert to having energy available to the self. Patients respond to eight prompts, with a response ranging from 1=strongly disagree to 7=strongly agree. The sum of the scores is calculated with a higher score indicating a better condition. The total score ranges from 8 to 56 with a higher score indicating a better condition.
| units on a scale | All Indications |
|---|---|
| Change From Baseline in Subjective Vitality Scale at Month 6 Across All Indications | -5.4 ± 8.3 |
HAQ-DI measures functional status in rheumatic diseases. It has 20 items, and asks patients to report the degree of difficulty faced in several areas of their life including: dressing and grooming, arising, eating, walking, hygiene, reach, grip, activities based on the previous week on a scale from 0 (without any difficulty) to 3 (cannot be done at all). It also asks the participant to rate their pain and health in the previous week. Scores on each task are summed and averaged to provide an overall score ranging from 0 (no disability) to 3 (very severe, high-dependency disability).
| score on a scale | Rheumatoid Arthritis |
|---|---|
| Change From Baseline in HAQ-DI Score at Month 6 in Participants With Rheumatoid Arthritis | 0.4 ± 0.4 |
The SIBDQ is a simple validated, 10-item questionnaire designed to find out how the patient has been feeling in the previous 2 weeks. QoL is measured in 4 domains: bowel symptoms, emotional health, systemic systems and social function. Participants respond to questions ranging from 1=all of the time to 7=none of the time. Scores are added together, with higher scores indicating a better health-related QoL. Total scores range from 10 (poor QoL) to 70 (good QoL).
| score on a scale | Crohn's Disease |
|---|---|
| Change From Baseline in SIBDQ Score at Month 6 in Participants With Crohn's Disease | -16.3 ± 13.7 |
The DLQI measures 10 items covering the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment, to determine how much the patients skin problem affected their life in the past week. Participants respond to the questions with 'very much,' 'a lot,' 'a little,' or 'not at all.' The scores are added together, and the impact on QoL is banded as follows: 0-1=no effect on participant's life; 2-5=small effect; 6-10=moderate effect; 11-20=very large effect; 21-30=extremely large effect.
| score on a scale | Psoriasis |
|---|---|
| Change From Baseline in DLQI Score at Month 6 in Participants With Psoriasis | 11.0 ± 7.6 |
The number of participants at 6 months who remained on adalimumab, having satisfied the requirements for application for renewal of subsidy by special authority.
| Participants | All Indications |
|---|---|
| Number of Participants Remaining on Treatment at Month 6 | 108 |
Collected over From the signing of informed consent through Month 6. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Indications | 1/164 (0.6%) | 18/164 (11%) | 65/164 (39.6%) |
| Event | All Indications |
|---|---|
| Crohn's diseaseGastrointestinal disorders | 3/164 |
| Gastritis erosiveGastrointestinal disorders | 1/164 |
| Intra-abdominal fluid collectionGastrointestinal disorders | 1/164 |
| Ileal stenosisGastrointestinal disorders | 1/164 |
| Small intestinal obstructionGastrointestinal disorders | 1/164 |
| VomitingGastrointestinal disorders | 1/164 |
| Abdominal herniaGeneral disorders | 1/164 |
| DeathGeneral disorders | 1/164 |
| Non-cardiac chest painGeneral disorders | 1/164 |
| Anal abscessInfections and infestations | 1/164 |
| Event | All Indications |
|---|---|
| Injection site reactionGeneral disorders | 4/164 |
| HeadacheNervous system disorders | 4/164 |
| NauseaGastrointestinal disorders | 3/164 |
| FatigueGeneral disorders | 3/164 |
| PainGeneral disorders | 3/164 |
| NasopharyngitisInfections and infestations | 3/164 |
| SinusitisInfections and infestations | 3/164 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 3/164 |
| AnxietyPsychiatric disorders | 3/164 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 3/164 |
Participants with baseline WHODAS data recorded. Per protocol, primary and secondary endpoint data \[other than the endpoints presented in Outcome Measures 4-6 and 14-16\] were intended to be analyzed across all indications; therefore, corresponding baseline data are presented for all participants as a single group.
| Age, Continuous(years) | All Indications |
|---|---|
| Mean | 45.7 (16.9 to 77.4) |
| Sex: Female, Male(Participants) | All Indications |
|---|---|
| Female | 103 |
| Male | 61 |
| Race/Ethnicity, Customized(Participants) | All Indications |
|---|---|
| Asian | 5 |
| European | 145 |
| Maori | 7 |
| Other (Not Specified) | 4 |
| Pacific Peoples | 3 |
| World Health Organization Disability Assessment Schedule (WHODAS) 2.0 Response Score(units on a scale) | All Indications |
|---|---|
| All Indications | 15.2 ± 9.1 |
| Crohn's disease | 13.2 ± 7.3 |
| Rheumatoid arthritis | 17.9 ± 8.1 |
| Psoriasis | 14.4 ± 11.7 |
| Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH) V2.0: Absenteeism(percentage of work time missed) | All Indications |
|---|---|
| Mean | 14.7 ± 30.0 |
| WPAI-GH v2.0: Presenteeism(percentage impairment time) | All Indications |
|---|---|
| Mean | 39.7 ± 28.8 |
| WPAI-GH v2.0: Work Productivity Loss(percentage overall work impairment) | All Indications |
|---|---|
| Mean | 29.4 ± 22.5 |
| WPAI-GH v2.0: Activity Impairment(percentage of activity impairment) | All Indications |
|---|---|
| Mean | 51.9 ± 28.1 |
6 further baseline measures are reported on the registry.
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